Download Section 3A- Criteria for Optional Special

Criteria for
Optional Special Authorization
of Select Drug Products
Section 3A Criteria for Optional Special Authorization of Select Drug Products
SECTION 3A
ALBERTA DRUG BENEFIT LIST
CRITERIA FOR OPTIONAL SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS
CRITERIA FOR OPTIONAL SPECIAL AUTHORIZATION
OF SELECT DRUG PRODUCTS
The drug products listed in this section may be considered for coverage by optional special
authorization for patients covered under Alberta Health-sponsored drug programs. (For Alberta
Human Services clients, the optional special authorization criteria for coverage can be found in the
Criteria for Optional Special Authorization of Select Drug Products section of the Alberta Human
Services Drug Benefit Supplement.)
Criteria for Coverage
70B
Wording that appears within quotation marks (“ “) in this section is the official optional special
authorization criteria, as recommended by the Alberta Health Expert Committee on Drug Evaluation
and Therapeutics, and approved by the Minister of Health. Wording that is not enclosed in quotation
marks outlines specific information required to interpret criteria, guidelines for submitting requests
and/or information regarding conditions under which coverage cannot be provided.
Role of the Prescribers
71B
In conjunction with the criteria, prescribers have two options by which patients may be eligible for
coverage of these select optional special authorization drug products.
1) Prescribers can register to be a designated prescriber. Registration allows for patients to receive
coverage of select drug products without special authorization as long as the prescription is written
for one of the criteria for coverage set out in this section. Should a designated prescriber wish to
prescribe one of the select drug products outside the coverage criteria, they may do so but must
indicate this on the prescription; however, patients will not be eligible for payment under the Alberta
government-sponsored program for such prescription and the patient may choose to receive the
product at their expense. The registration form may be found on the previous page.
2) Prescribers who choose not to register will be considered non-designated prescribers. Such
prescribers will be required to apply for special authorization on the patient’s behalf.
The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize Professional judgment.
EFFECTIVE APRIL 1, 2016
Section 3A
ALBERTA DRUG BENEFIT LIST
CRITERIA FOR OPTIONAL SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS
Criteria For Optional Special Authorization Of Select Drug Products
Patient claims for select quinolone prescriptions written by a non-designated prescriber will be subject to a first forgiveness
rule, meaning the first claim will be paid. Subsequent claims for the same product (irrespective of strength, route and form)
within a 90-day period would require the prescriber to apply for special authorization for coverage on the patient’s behalf.
CIPROFLOXACIN
"For the treatment of:
1) Respiratory Tract Infections:
-end stage COPD with or without bronchiectasis, where there has been documentation of
previous Pseudomonas aeruginosa colonization/infection or
- pneumonic illness in cystic fibrosis; or
2) Genitourinary Tract Infections:
- urinary tract infections,
- prostatitis,
- prophylaxis of urinary tract surgical procedures or
- gonococcal infections; or
3) Skin and Soft Tissue/Bone and Joint Infections:
- malignant/invasive otitis externa,
- bone/joint infections due to gram negative organisms or
- therapy/step-down therapy of polymicrobial infections in combination with clindamycin or
metronidazole e.g. diabetic foot infection, decubitus ulcers; or
4) Gastrointestinal Tract Infections:
- bacterial gastroenteritis where antimicrobial therapy is indicated,
- typhoid fever (enteric fever), or
- therapy/step-down therapy of polymicrobial infections in combination with clindamycin or
metronidazole e.g. intra-abdominal infections; or
5) Other:
- prophylaxis of adult contacts of cases of invasive meningococcal disease,
- therapy/step-down therapy of hospital acquired gram negative infections,
- empiric therapy of febrile neutropenia in combination with other appropriate agents or
- exceptional case of allergy or intolerance to all other appropriate therapies as defined by
relevant guidelines/references i.e. AMA CPGs or Bugs and Drugs.
- for use in other current Health Canada approved indications when prescribed by a specialist in
Infectious Diseases."
All requests for ciprofloxacin must be completed using the Select Quinolones Special
Authorization Request Form (ABC 30966).
100 MG / ML
ORAL SUSPENSION
00002237514
CIPRO
BAI
$
0.5750
The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.
UNIT OF ISSUE - REFER TO PRICE POLICY
EFFECTIVE APRIL 1, 2016
Section 3A . 1
ALBERTA DRUG BENEFIT LIST
CRITERIA FOR OPTIONAL SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS
CIPROFLOXACIN HCL
"For the treatment of
1) Respiratory Tract Infections:
- end stage COPD with or without bronchiectasis, where there has been documentation of
previous Pseudomonas aeruginosa colonization/infection; or
- pneumonic illness in cystic fibrosis; or
2) Genitourinary Tract Infections:
- urinary tract infections; or
- prostatitis; or
- prophylaxis of urinary tract surgical procedures; or
- gonococcal infections; or
3) Skin and Soft Tissue/Bone and Joint Infections:
- malignant/invasive otitis externa; or
- bone/joint infections due to gram negative organisms; or
- therapy/step-down therapy of polymicrobial infections in combination with clindamycin or
metronidazole e.g. diabetic foot infection, decubitus ulcers; or
4) Gastrointestinal Tract Infections:
- bacterial gastroenteritis where antimicrobial therapy is indicated; or
- typhoid fever (enteric fever); or
- therapy/step-down therapy of polymicrobial infections in combination with clindamycin or
metronidazole e.g. intra-abdominal infections; or
5) Other:
- prophylaxis of adult contacts of cases of invasive meningococcal disease; or
- therapy/step-down therapy of hospital acquired gram negative infections; or
- empiric therapy of febrile neutropenia in combination with other appropriate agents; or
- exceptional case of allergy or intolerance to all other appropriate therapies as defined by
relevant guidelines/references i.e. AMA CPGs or Bugs and Drugs; or
- for use in other current Health Canada approved indications when prescribed by a specialist in
Infectious Diseases."
All requests for Ciprofloxacin must be completed using the Select Quinolones Special
Authorization Request Form (ABC 30966).
250 MG (BASE)
ORAL TABLET
00002380358
00002426978
00002247339
00002229521
00002381907
00002332132
00002353318
00002386119
00002379686
00002423553
00002245647
00002161737
00002248437
00002303728
00002246825
00002248756
00002379627
00002155958
JAMP-CIPROFLOXACIN
VAN-CIPROFLOXACIN
ACT CIPROFLOXACIN
APO-CIPROFLOX
AURO-CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
MAR-CIPROFLOXACIN
MINT-CIPROFLOX
MYLAN-CIPROFLOXACIN
NOVO-CIPROFLOXACIN
PMS-CIPROFLOXACIN
RAN-CIPROFLOX
RATIO-CIPROFLOXACIN
SANDOZ CIPROFLOXACIN
SEPTA-CIPROFLOXACIN
CIPRO
JPC
VAN
APH
APX
AUR
RAN
SNS
SIV
MAR
MPI
MYP
TEV
PMS
RAN
RPH
SDZ
SEP
BAI
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
0.6186
0.6186
0.6248
0.6248
0.6248
0.6248
0.6248
0.6248
0.6248
0.6248
0.6248
0.6248
0.6248
0.6248
0.6248
0.6248
0.6248
2.4964
The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.
PRODUCT IS NOT INTERCHANGEABLE
Section 3A . 2
EFFECTIVE APRIL 1, 2016
ALBERTA DRUG BENEFIT LIST
CRITERIA FOR OPTIONAL SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS
CIPROFLOXACIN HCL
500 MG (BASE)
ORAL TABLET
00002380366
00002427001
00002247340
00002229522
00002381923
00002332140
00002353326
00002386127
00002379694
00002423561
00002245648
00002161745
00002248438
00002303736
00002246826
00002248757
00002379635
00002155966
750 MG (BASE)
JAMP-CIPROFLOXACIN
VAN-CIPROFLOXACIN
ACT CIPROFLOXACIN
APO-CIPROFLOX
AURO-CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
MAR-CIPROFLOXACIN
MINT-CIPROFLOX
MYLAN-CIPROFLOXACIN
NOVO-CIPROFLOXACIN
PMS-CIPROFLOXACIN
RAN-CIPROFLOX
RATIO-CIPROFLOXACIN
SANDOZ CIPROFLOXACIN
SEPTA-CIPROFLOXACIN
CIPRO
JPC
VAN
APH
APX
AUR
RAN
SNS
SIV
MAR
MPI
MYP
TEV
PMS
RAN
RPH
SDZ
SEP
BAI
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
0.6979
0.6979
0.7049
0.7049
0.7049
0.7049
0.7049
0.7049
0.7049
0.7049
0.7049
0.7049
0.7049
0.7049
0.7049
0.7049
0.7049
2.8166
JPC
VAN
APH
APX
RAN
MAR
MPI
MPI
MYP
TEV
PMS
RAN
RPH
SDZ
SEP
BAI
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
1.2780
1.2780
1.2908
1.2908
1.2908
1.2908
1.2908
1.2908
1.2908
1.2908
1.2908
1.2908
1.2908
1.2908
1.2908
5.1578
ORAL TABLET
00002380374
00002427028
00002247341
00002229523
00002332159
00002379708
00002423588
00002317443
00002245649
00002161753
00002248439
00002303744
00002246827
00002248758
00002379643
00002155974
JAMP-CIPROFLOXACIN
VAN-CIPROFLOXACIN
ACT CIPROFLOXACIN
APO-CIPROFLOX
CIPROFLOXACIN
MAR-CIPROFLOXACIN
MINT-CIPROFLOX
MINT-CIPROFLOXACIN
MYLAN-CIPROFLOXACIN
NOVO-CIPROFLOXACIN
PMS-CIPROFLOXACIN
RAN-CIPROFLOX
RATIO-CIPROFLOXACIN
SANDOZ CIPROFLOXACIN
SEPTA-CIPROFLOXACIN
CIPRO
The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.
UNIT OF ISSUE - REFER TO PRICE POLICY
Section 3A . 3
EFFECTIVE APRIL 1, 2016
ALBERTA DRUG BENEFIT LIST
CRITERIA FOR OPTIONAL SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS
LEVOFLOXACIN
"To be prescribed according to ONE of the following criteria:
For the treatment of
1) Community acquired pneumonia after failure of first line therapy, as defined by clinical
deterioration after 72 hours of antibiotic therapy or lack of improvement after completion of
antibiotic therapy; or
2) Community acquired pneumonia in patients with co-morbidities (asthma, lung cancer, COPD,
diabetes, alcoholism, chronic renal or liver failure, CHF, chronic corticosteroid use, malnutrition
or acute weight loss, hospitalization within previous 3 months, HIV/AIDS, smoking); or
3) Acute exacerbation of chronic bronchitis after failure of first and second line therapy, as
defined by clinical deterioration after 72 hours of antibiotic therapy or lack of improvement after
completion of antibiotic therapy; or
4) Acute sinusitis after failure of first line therapy, as defined by clinical deterioration after 72 h of
antibiotic therapy or lack of improvement after completion of antibiotic therapy, in patients with
beta-lactam (penicillin and cephalosporin) allergy; or
5) For use in other current Health Canada approved indications when prescribed by a specialist
in Infectious Diseases."
All requests for Levofloxacin must be completed using the Select Quinolones Special
Authorization Request Form (ABC 30966).
250 MG
ORAL TABLET
00002315424
00002284707
00002313979
00002248262
00002284677
00002298635
500 MG
APH
APX
MYP
TEV
PMS
SDZ
$
$
$
$
$
$
1.2038
1.2038
1.2038
1.2038
1.2038
1.2038
APH
APX
MYP
TEV
PMS
SDZ
$
$
$
$
$
$
1.3718
1.3718
1.3718
1.3718
1.3718
1.3718
APH
APX
TEV
PMS
SDZ
$
$
$
$
$
4.8478
4.8478
4.8478
4.8478
4.8478
ORAL TABLET
00002315432
00002284715
00002313987
00002248263
00002284685
00002298643
750 MG
ACT LEVOFLOXACIN
APO-LEVOFLOXACIN
MYLAN-LEVOFLOXACIN
NOVO-LEVOFLOXACIN
PMS-LEVOFLOXACIN
SANDOZ LEVOFLOXACIN
ACT LEVOFLOXACIN
APO-LEVOFLOXACIN
MYLAN-LEVOFLOXACIN
NOVO-LEVOFLOXACIN
PMS-LEVOFLOXACIN
SANDOZ LEVOFLOXACIN
ORAL TABLET
00002315440
00002325942
00002285649
00002305585
00002298651
ACT LEVOFLOXACIN
APO-LEVOFLOXACIN
NOVO-LEVOFLOXACIN
PMS-LEVOFLOXACIN
SANDOZ LEVOFLOXACIN
The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.
PRODUCT IS NOT INTERCHANGEABLE
EFFECTIVE APRIL 1, 2016
Section 3A . 4
ALBERTA DRUG BENEFIT LIST
CRITERIA FOR OPTIONAL SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS
MOXIFLOXACIN HCL
"To be prescribed according to ONE of the following criteria:
For the treatment of
1) Community acquired pneumonia after failure of first line therapy, as defined by clinical
deterioration after 72 hours of antibiotic therapy or lack of improvement after completion of
antibiotic therapy; or
2) Community acquired pneumonia in patients with co-morbidities (asthma, lung cancer, COPD,
diabetes, alcoholism, chronic renal or liver failure, CHF, chronic corticosteroid use, malnutrition
or acute weight loss, hospitalization within previous 3 months, HIV/AIDS, smoking); or
3) Acute exacerbation of chronic bronchitis after failure of first and second line therapy, as
defined by clinical deterioration after 72 hours of antibiotic therapy or lack of improvement after
completion of antibiotic therapy; or
4) Acute sinusitis after failure of first line therapy, as defined by clinical deterioration after 72 h of
antibiotic therapy or lack of improvement after completion of antibiotic therapy, in patients with
beta-lactam (penicillin and cephalosporin) allergy; or
5) For use in other current Health Canada approved indications when prescribed by a specialist
in Infectious Diseases."
All requests for Moxifloxacin HCl must be completed using the Select Quinolones Special
Authorization Request Form (ABC 30966).
400 MG (BASE)
ORAL TABLET
00002432242
00002443929
00002447061
00002447053
00002375702
00002242965
AURO-MOXIFLOXACIN
JAMP-MOXIFLOXACIN
JAMP-MOXIFLOXACIN
MAR-MOXIFLOXACIN
TEVA-MOXIFLOXACIN
AVELOX
AUR
JPC
JPC
MAR
TEV
BAI
$
$
$
$
$
$
1.5230
1.5230
1.5230
1.5230
1.5230
6.0858
The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.
UNIT OF ISSUE - REFER TO PRICE POLICY
EFFECTIVE APRIL 1, 2016
Section 3A . 5